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PainNCT06583668

The Effect of Therapeutic Story on Pain, Fear and Anxiety Levels

A study testing Therapeutic Story in people with Pain and Burns, run by Okan University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Aim: The aim of this study was to evaluate the effect of therapeutic story on pain, anxiety, fear and physiological parameters in children undergoing burn dressing. Methods: A randomised controlled trial was conducted between April 2023 and June 2024 with 60 patients who were admitted to the burn unit of a hospital in… Read more about this study

Who is it for?
Ages 3 to 6 yearsHealthy volunteers can take part
Conditions the study is for
Pain, Burns, Fear
What is being tested?
Therapeutic Story
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Apr 2023to 1 Jul 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 to 6 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • - To be between 3-6 years old,
  • Consideration of the first dressing of the child in the burn centre
  • 2nd degree superficial and deep burns (2nd degree burns requiring hospital treatment and high pain level)
  • Percentage of burns below 10 per cent (light sedation for children with burn injuries above 10 per cent)
  • Not having any chronic disease other than burns
  • The child's willingness to participate in the research
  • It is the absence of mental, communication problems and visual impairment.

Who cannot join

  • • The child's dressing has been done in a burn center before
  • Presence of 1st and 3rd degree burn areas
  • Burn percentage is over 10%

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Istanbul- City Hospital

    Istanbul

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Therapeutic Story on Pain, Fear and Anxiety Levels in Children With Burn Dressing

Aim: The aim of this study was to evaluate the effect of therapeutic story on pain, anxiety, fear and physiological parameters in children undergoing burn dressing.

Methods: A randomised controlled trial was conducted between April 2023 and June 2024 with 60 patients who were admitted to the burn unit of a hospital in Istanbul and met the inclusion criteria. Patients in the story group (n=30) were listened to the digitised story during burn dressing, while patients in the control group (n=30) did not receive any intervention other than routine care. Data were collected using the Descriptive Characteristics Form, Child Anxiety Scale-Situation Scale, Child Fear Scale, Wong-Barker Pain Scale, Parental Satisfaction Scale (VAS) and Physiological Parameters Form.

Conditions
Pain, Burns, Fear, Anxiety
Being tested
Therapeutic Story
Keywords
Anxiety, Burn, Child, Pain, Fear
Medical subject headings
Pain, Burns, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Therapeutic StoryOther

    Listening and watching the therapeutic story in digital media

Study groups in NCT06583668
Study groupRoleWhat they receive
Experimental: Therapeutic Story groupExperimentalI. Assessment:Before the burn dressing II. Assessment: During burn dressing II. Assessment: After burn dressing
Receives: Other: Therapeutic Story
Standard careNo interventionI. Assessment:Before the burn dressing II. Assessment: During burn dressing II. Assessment: After burn dressing

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The effect of therapeutic history on pain

    Wong Barker Pain Scale The Facial Expressions Rating Scale (Wong Baker) consists of six facial expressions. The facial expressions are graded as 'No pain=0 points' and 'Unbearable pain=10 points'. It is a scale based on the child's self-report and is suitable for use in children aged 3-18 years. In this scale, pain scores are given according to the numerical values given to the faces. The lowest score is '1' and the highest score is '5'. As the score obtained from the scale increases, pain tolerance decreases and as the score decreases, tolerance increases.

    This scale was used before, during and after the burn dressing.

    Measured: 15 month

  2. The effect of therapeutic history on fear

    The scale is used to assess fear in children aged 4-10 years. The scale consists of five drawn facial expressions ranging from neutral expression (0=no anxiety) to frightened face (4=severe anxiety).

    This scale was used before, during and after the burn dressing.

    Measured: 15 month

  3. The effect of therapeutic history anxiety

    Child Anxiety Scale-Dispositional (CAS-D) Scale The Child Anxiety Scale-Dispositional (CAS-D) Scale aims to determine the anxiety levels of children aged 4-10 years. The CAS-D is shaped like a thermometer with a light bulb at the bottom and horizontal lines with intervals going upwards. In order to measure the state anxiety level, the child is asked to mark how he/she feels 'at the moment'. A transparent metre is placed over the child's rating on which ½ point increments are marked, then the ½ point increment is rounded up to the nearest number. The score can range from 0 to 10.It is determined that as the score value increases, the anxiety level increases, and as the score value decreases, the anxiety level decreases.

    This scale was used before, during and after the burn dressing.

    Measured: 15 month

Secondary outcomes (4)

  1. The effect of the therapeutic story applied to children on parents' anxiety levels

    State-Trait Anxiety Scale (STAI) The scale has 20 items and is graded between 1-4. The total score obtained from the scale is between 20-80. If the score obtained from the scales is low, it indicates that the anxiety of the individual is low, and if it is high, it indicates that the anxiety of the individual is high.

    Measured: 15 month

  2. The effect of therapeutic history on blood pressure/systolic -diastolic

    Physiological Parameters Form Blood pressureof the patients were obtained with a form prepared by the investigator. Blood pressure; includes systolic and diastolic blood pressure valuesThis form was used before, during and after the burn dressing.

    Measured: 15 month

  3. The effect of therapeutic history on pulse rate

    Physiological Parameters Form pulse rate of the patients were obtained with a form prepared by the investigator. This form was used before, during and after the burn dressing.

    Measured: 15 month

  4. The effect of therapeutic history on saturation levels

    Physiological Parameters Form saturation levels of the patients were obtained with a form prepared by the investigator. This form was used before, during and after the burn dressing.

    Measured: 15 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Sep 2024
  2. Study start1 Apr 2023
  3. Primary completion1 Jun 2024
  4. Study completion1 Jul 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06583668
Sponsor's protocol ID
NSS0
Status last verified
Sep 2024
First submitted
27 Aug 2024
Last updated
19 Sep 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Hawker GA, Mian S, Kendzerska T, French M. Measures of adult pain: Visual Analog Scale for Pain (VAS Pain), Numeric Rating Scale for Pain (NRS Pain), McGill Pain Questionnaire (MPQ), Short-Form McGill Pain Questionnaire (SF-MPQ), Chronic Pain Grade Scale (CPGS), Short Form-36 Bodily Pain Scale (SF-36 BPS), and Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11:S240-52. doi: 10.1002/acr.20543. No abstract available.

    PubMed 22588748

  • Farzan R, Parvizi A, Haddadi S, Sadeh Tabarian M, Jamshidbeigi A, Samidoust P, Ghorbani Vajargah P, Mollaei A, Takasi P, Karkhah S, Firooz M, Hosseini SJ. Effects of non-pharmacological interventions on pain intensity of children with burns: A systematic review and meta-analysis. Int Wound J. 2023 Sep;20(7):2898-2913. doi: 10.1111/iwj.14134. Epub 2023 Mar 1.

    PubMed 36859758

  • Chester SJ, Stockton K, De Young A, Kipping B, Tyack Z, Griffin B, Chester RL, Kimble RM. Effectiveness of medical hypnosis for pain reduction and faster wound healing in pediatric acute burn injury: study protocol for a randomized controlled trial. Trials. 2016 Apr 29;17(1):223. doi: 10.1186/s13063-016-1346-9.

    PubMed 27129580

  • Jeffs D, Dorman D, Brown S, Files A, Graves T, Kirk E, Meredith-Neve S, Sanders J, White B, Swearingen CJ. Effect of virtual reality on adolescent pain during burn wound care. J Burn Care Res. 2014 Sep-Oct;35(5):395-408. doi: 10.1097/BCR.0000000000000019.

    PubMed 24823326

Questions about this trial

What is this clinical trial studying?

A study testing Therapeutic Story in people with Pain and Burns, run by Okan University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The effect of therapeutic history on pain (time frame: 15 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06583668, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.

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